Dysmenorrhea Clinical Trial
Official title:
A Comparison of Long Term Outcomes Following Total Laparoscopic Hysterectomy and Laparoscopic Supracervical Hysterectomy.
Objective: To compare the occurrence and intensity of pelvic pain as well as patient
satisfaction and quality of life after total laparoscopic and laparoscopic supracervical
hysterectomy.
Design: Prospective randomised trial.
Null hypothesis 1: There is no significant difference in occurrence and intensity of pelvic
pain following TLH compared with following LSH.
Null hypothesis 2: There is no significant difference in patient satisfaction and quality of
life following TLH compared with following LSH.
Sample: 62 consecutive premenopausal women referred to the department for hysterectomy on
the basis of a benign condition. The expected mean pain reduction (m) in the LSH group:
3.32, sd (s): 2.71.24 A difference in mean pain reduction (d) equal to 1 sd is considered a
clinically important improvement (standardised difference d/s=1). Number of women required
(power 90 % and a level of significance 0.05): 62 patients.
Methods: The study participants are randomised to total laparoscopic hysterectomy (n = 31),
or laparoscopic supracervical hysterectomy (n = 31).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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